Bed sores are lesions that form in the derma. Bed sores are often referred to as pressure ulcers or decubitus ulcers, sometimes improperly, as they may also be caused by forces other than pure pressure, such as shear and friction forces. These lesions may be caused by a number of different types of tissue forces, 1) pressure, or the compression of tissues; 2) shear force, where a patient's skin remains stationary while the deep fascia and skeletal muscle move, usually downward due to gravity; and 3) friction, or a force resisting the shearing of skin. The frequency, severity and duration of decubitus ulcers may be aggravated by humidity; temperature; age; continence and medication. While decubitus ulcers may erupt on any part of the body, they are especially prone on portions of the body over bony or cartilaginous areas such as hips, spine, lower back area, shoulders, sacrum, elbows, knees, ankles and heels.
Of the three tissue forces, decubitus ulcers occurring from pressure are the most prevalent, and some experts insist, are the most easily preventable and treatable type of wound. Pressure, or compression sores are caused by the weight (or force) of a portion of the body (usually proximate to a bone) against a surface. A patient is most at risk of forming or worsening of decubitus ulcers by remaining in a decubitus (recumbent) position for a lengthy period without moving. Essentially, blood circulation to an area is restricted by the pressure exerted on the tissue, usually located between a bone and the surface of a bed. An open lesion can form in as little as two or three hours. After an extended amount of time with decreased tissue perfusion, ischemia occurs and can lead to tissue necrosis if left untreated. Obviously, bedridden patients, who can not reposition themselves, are among the most susceptible to develop pressure sores on their body.
The National Pressure Ulcer Advisory Panel (NPUAP) has categorized pressure ulcerations into four distinct stages: Stage I is the most superficial, indicated by non blanchable redness that does not subside after pressure is relieved. Stage II is damage in the form of a blister or abrasion to the epidermis extending into, but no deeper than, the dermis. Stage III involves the full thickness of the skin and may extend into the subcutaneous tissue layer. Stage IV pressure ulcer is the deepest, extending into the muscle, tendon or even bone. With higher stages, healing time is prolonged. For instance, while approximately 75% of Stage II ulcers heal within eight weeks, only 62% of Stage IV pressure ulcers ever heal, and only 52% heal within one year. (see Thomas D R, Diebold M R, Eggemeyer L M (2005). “A controlled, randomized, comparative study of a radiant heat bandage on the healing of stage 3-4 pressure ulcers: a pilot study”. J Am Med Dir Assoc 6 (1): 46-9. doi:10.1016/j.jamda.2004.12.007. PMID 15871870). Therefore, it is imperative for the patient that: 1) the occurrence of decubitus ulcers be prevented; and 2) decubitus ulcers that have formed be aggressively treated and the treatment and progression of the sores monitored. Furthermore, while it was once accepted that decubitus ulcers form at the surface of the skin, which first begins to deteriorate and then proceeds inward toward deep tissue, it is now believed that the ulcers begin at the deepest tissue level, around the bone, and move outward until they reach the epidermis. Hence, once a bed sore becomes visible, there may be a significant amount of hidden tissue damage.
The Agency for Health Care Policy and Research has promulgated a set of clinical practice guidelines with recommendations for the prediction, prevention, and early treatment of pressure ulcers in adults and which provides a summary of supporting evidence for each recommendation. AHCPR. (1992, May). Panel for the Prediction and Prevention of Pressure Ulcers in Adults. Pressure Ulcers in Adults: Prediction and Prevention. Clinical Practice Guideline, Number 3. AHCPR Publication No. 92-0047. Rockville, Md.: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. Level VI: Expert Panel Consensus.
The prevention and treatment of decubitus ulcers had escaped medical professionals for centuries, even though they presented a significant patient mortality risk, until Doreen Norton, FRCN (1922-2007) used research to demonstrate that the best prevention and treatment for decubitus ulcers was removing the pressure on the patient by turning the patient. “Turning” refers to exactly what it sounds like, turning the patient, or changing the patient's position, to prevent the build-up of pressure on the skin that can result in the loss of circulation. Since Doreen Norton's research, turning has been universally accepted as the most important factor in bed sore prevention. Yet, despite its universal acceptance, many healthcare facilities (hospitals and nursing homes) fail to properly implement turning techniques.
Recently, patient decubitus ulcers have become a hotspot for malpractice litigation primarily due to three factors: sympathetic plaintiffs (often bedridden or immobile patients); the demonstrability of the harm (decubitus ulcers are easily memorialized in pictures that convey credible record of harm to the plaintiff); and finally, it can be readily demonstrated that the treatment of the vast majority of cases is a simple protocol of evaluating the severity of the sore, implementing a turning regimen and monitoring the results. Juries are rightly concluding that the cost of prevention and treatment of decubitus ulcers is very low in comparison to the extreme harm that results from no or ineffective treatment. Another complication related to decubitus ulcers is their classification as ‘Never Events’, which are events defined by Medicare and the insurance industry as events that should never happen in a hospital. Because patient decubitus ulcers are considered to be completely preventable, most insurers will not reimburse healthcare facilities for the cost of treating patient's decubitus ulcers that erupted during a patient stay. If the hospital allows a patient to develop a bed sore, the hospital is responsible for all subsequent care for that sore.
To that end, some healthcare facilities have implemented specific steps to reduce the occurrence and severity of bed sores, and hence any potential costs and liability. Firstly, and perhaps most important is to identify and document the location(s) and severity of decubitus ulcers on all new admissions. Next, a related step is to encourage the staff to look for and document bed sores, even in their earliest stages. Moreover, any staff member, regardless of their job, is encouraged to alert physicians and supervisors of patients with bed sores, even the early signs of bed sores. Patients who are bed bound or whose skin comes into contact with medical equipment like oxygen masks or tubing deserve additional attention from the staff. Finally, many healthcare facilities also implement a strict wound prevention protocol for implementing daily skin checks, a patient repositioning regimen, followed up by intensive, hospital-wide skin checks on a regular basis to assess the effectiveness of the protocol.
Turning, or repositioning a patient, is a relatively uncomplicated concept, however properly implementing turning techniques is hard, labor-intensive work. Consequently, patient turning is often performed haphazardly at irregular intervals, without any objective means for documenting the procedure, or oversight from the healthcare facility. Ideally, patient turning should be completed at intervals set forth by a physician and in the manner prescribed by the physician. Moreover, the healthcare facility should have minimum guidelines for preventing the occurrence of bed sores without specific patient orders from a physician. For instance, the turning of patients at least every two hours is often considered to be the minimally accepted interval. Depending on the condition of the patient, turning may be required more frequently. Ideally, the patient turns himself to the correct position at the prescribed interval. However, many bedridden patients cannot accomplish this task without assistance, so the healthcare facility staff should reposition the patient in accordance with directions from the attending physician or facility guidelines. Additionally, for patients who spend a significant amount of time in wheelchairs, the healthcare facility staff periodically removes the patient from their seat and then repositions the patient in the wheelchair, again, at the interval and as directed by the attending physician.
Implementing bed sore abatement regimen has been a manually intensive procedure, as has been protocols for documenting the regimen. Typically, a physician prescribes a particular turning regimen for a specific patient. Ideally, the bed sore prevention regimen can be integrated seamlessly into the caregiver's routine without any additional patient visits that might interfere with the routines of other patients. As a practical matter, however, most turning regimens require between three and eight additional patient visits per twelve hour shift. Because each patient assigned to a healthcare provider may have a unique turning interval (also referred to hereinafter as an intervention interval, healthcare professional intervention interval and nurse intervention interval), keeping the separate patient turning schedules is problematic. Thus, conflicts between patients' turning schedules are commonplace, with the labor-intensive turning procedures usually being subservient to more effortless care. Furthermore, the staff is rarely aware of any unaided patient movements that might satisfy the turning protocol. The penchant for postponing or outright skipping turning procedures in view of seemingly conflicting and less strenuous patient care can be mitigated somewhat by a rigorous bed sore prevention documentation procedure and strict oversight. When healthcare professionals are held strictly accountable for implementing the regimen, they rarely falter. Of course, oversight is yet another manually intensive task that consumes valuable time from supervisory personnel. Hence, the documentation of turning and turning intervals is usually an additional responsibility assigned to the same healthcare professionals responsible for turning the patient. Obviously, this encourages fraudulent reporting, especially in situations where the caregiver is exceptionally busy, overworked or detained with more serious patient matters.
Recently, there has been a trend to automate scheduling and documentation of the bed sore prevention regimen. However, many of these efforts involve essentially recycling known technology for the prevention of bed sores. U.S. Pat. No. 7,378,975 entitled “Method and Apparatus for Mitigating the Risk of Pressure Sores,” issued to Smith, et al. on May 27, 2008 discloses using a pressure sensor (such as a pressure-sensitive bed mat) in conjunction with a timer to alert healthcare professionals to the expiration of a turn interval for the patient. The use of pressure sensors for assessing a patient's presence on a bed for other support structures is extremely well known for patient fall detection. Smith, et al. describe a method that integrates patient movement detection into a fall detection procedure for alerting the healthcare staff of the expiration of a patient turn interval. Essentially, the patient pressure sensor mat senses the position of a patient by individual electrical contacts within the mat. Initially, a patient's position on the sensor mat is assessed and a turn timer reset for the turn interval. The turn timer continues to count down to the turn time unless a change is sensed at the pressure sensor mat. That change may involve movement indicative of a turn, movement indicative of the patient exiting the bed or movement not indicative of a turn. Once movement is sensed it is analyzed to determine if the patient left the bed, If so an alarm sounds and the turn timer is reset. If not, the system invokes a subroutine to determine if the movement is significant. A “significant move” is defined as a patient movement to a new location that is maintained long enough to re-oxygenate the at risk tissue. Hence, if a patient movement is determined to be to a new location on the pressure sensitive mat, apparently a second timer is initiated for testing the time at the new location. If sufficiently long, the turn timer resets the turn interval. If not, the turn timer continues counting the turn interval. Smith, et al. also suggests the use of infrared and ultrasonic motion sensors, as well as a conventional or infrared video camera for sensing patient movement.
The Smith, et al. invention has two distinct advantages over the prior art. Firstly the turning regimen prescribed for a patient may be satisfied by unaided patient movements, thereby eliminating duplicative and unnecessary turning. Secondly, the healthcare staff is automatically alerted to the expiration of a turn interval, regardless of when or how the interval commenced. In so doing, the attention of the staff is only necessary when turning is actually necessary.
The shortcomings with the prior art is that the detected patient movement may not actually satisfy the turning protocol, yet the turn timer may reset. Additionally, turning, or patient movement, is not documented. Documentation, with the exception of possibly noting the issue of a turn alert, apparently remains the responsibility of the turn staff. Finally, the Smith, et al. invention is directed to a labor-saving device that, based on certain parameters in the system, postpones caregiver turning.